Quality Control Officer

About the Role

The Quality Control Officer at Cipla's Saudi Arabia facility plays a vital role in supporting the Quality Control operations, ensuring timely execution of laboratory qualifications, validation activities, instrument procurement, and area qualification. The position demands robust scientific and analytical troubleshooting expertise for out-of-specification/out-of-trend results, deviations, impurity analysis, and regulatory compliance while adhering to cGMP, data integrity, and the requirements of SFDA and other global regulatory agencies.

Key Responsibilities

• Manage project deliverables including preparation of documents such as URS, SIA, PRA, and GxP for procurement of new laboratory instruments and equipment.
• Perform qualification of received instruments and equipment in the QC laboratory following SOPs and protocols.
• Conduct QC area qualifications including temperature mapping, ensuring completion within defined timelines.
• Execute assigned QC tasks from the Section Head and prioritize critical QC activities like scheduled calibrations and AMC for instruments and equipment.
• Prepare protocols, reports, chromatographic data, analytical justifications, and laboratory documentation ensuring "right-first-time" completion and timely closure.
• Maintain compliance with cGMP, data integrity principles including ALCOA++, and regulatory expectations.
• Ensure inspection readiness for regulatory bodies such as SFDA, EU GMP, MHRA, WHO, and PIC/S.
• Support regulatory and customer audits including preparing technical responses backed by sound analytical justification.
• Train analysts on techniques like HPLC/UPLC, GC, UV, FTIR, dissolution testing, and advanced analytical evaluations.
• Promote a culture of compliance, safety, and scientific decision-making within the QC section.

Candidate Profile and Requirements

• A minimum education qualification of M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry is preferred.
• Between 8 to 10 years of extensive experience in pharmaceutical quality control including non-routine analysis, method validation and verification, method transfer, computer system validation (CSV), instrument calibration, validation, qualification, stability studies, and routine analytics.
• Strong expertise with analytical instrumentation and techniques including HPLC, GC, UV, FTIR, dissolution analysis, impurity profiling, forced degradation, and stability evaluations.
• Comprehensive knowledge of cGMP, ALCOA++, data integrity, and regulatory standards from SFDA, EU GMP, MHRA, WHO, PIC/S, and ICH guidelines.
• Solid skills in analytical troubleshooting, CSV, investigation of OOS/OOT results, root cause analysis (RCA), risk assessments, and CAPA management.
• Capability to support new product introduction, technology transfers, and regulatory audit responses, specifically for projects in Saudi Arabia.